Data Review Specialist - Bioassays

Randstad Life Sciences US; Norwood (MA); On-site; USD 55,104 - 70,257; Full time

Benefits offered by this job

Comprehensive benefits package

401K contribution

Health insurance

Job summary

A leading life sciences staffing firm is looking for a Data Review Specialist - Bioassays in Norwood, MA. This contract role is for a highly experienced professional with a Bachelor's degree in a scientific field and over 5 years of GMP QC lab experience. Responsibilities include rigorous data review, managing quality systems, and supporting investigations in a collaborative environment. Competitive hourly rate offered.

Qualifications

• 5+ years of direct experience in GMP QC labs.
• Experience performing Bioassay methods (e.g. DNA Sequencing, PCR).
• Experience managing quality records and conducting audits.

Responsibilities

• Review executed QC Bioassay test records.
• Maintain and update training documentation.
• Support authoring quality systems records.

Skills

Data review

GMP compliance

Quality systems management

Bioassay methods

Investigative skills

Education

BA or BS degree in Biology, Chemistry, or similar field

Job description

Join to apply for the Data Review Specialist - Bioassays role at Randstad Life Sciences US

Contract – Potential to last 6 Months, to start

Location: Norwood, MA

Pay range: PR: $40-51/hour

Job Summary

Step into a critical contract role as a Data Review Specialist - Bioassays in Norwood, MA, offering a competitive rate of $40-$51/hour. This position is ideal for a highly experienced professional with a Bachelor's degree in a scientific field (Biology, Chemistry, or similar) and 5+ years of direct experience in GMP QC labs. The specialist will be responsible for the rigorous data review and release of executed QC Bioassay test records, ensuring strict GDP/GMP compliance, including audit trail review. Core functions also involve managing quality systems by authoring and revising SOPs, procedures, and reports, and supporting the creation of quality records such as deviations, change controls, and CAPAs, while contributing to investigations and troubleshooting efforts.

Job Responsibilities

• Review executed QC Bioassay test records for product release.
• Work with QC group to maintain and update all necessary training documentation including On-The-Job Trainings, Training Materials, Instructor Led Training, and Knowledge Checks.
• Support authoring and revision of laboratory procedures and reports.
• Support authoring quality systems records such as deviations, change controls, CAPAs as required.
• Support team to investigate and resolve issues related to assay failures, system deficiencies, and equipment/assay troubleshooting.
• Additional duties may be assigned.

Education & Qualifications

• BA or BS degree in Biology, Chemistry, or similar field.
• 5+ years of direct experience in GMP QC labs with experience performing Bioassay methods (e.g. DNA Sequencing, Electrophoresis, PCR, Residual Protein Assays, and Cell Culture).
• Previous experience reviewing data for GDP/GMP compliance as well as audit trail review.
• Previous experience managing quality records such as change controls, deviations, and lab investigations.
• A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).

Seniority level

Associate

Employment type

Contract

Job function

Science and Research

Industries

Pharmaceutical Manufacturing and Biotechnology Research

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